Senior Clinical Research Associate managing clinical trials for Thermo Fisher Scientific in Germany. Conducting site monitoring, ensuring compliance, and maintaining data accuracy across multiple locations.
Responsibilities
Performs and coordinates all aspects of the clinical monitoring and site management process.
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
Ensures audit readiness.
Develops collaborative relationships with investigational sites.
Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
Conducts monitoring tasks in accordance with the approved monitoring plan.
Participates in investigator meetings as necessary.
Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
Requirements
Bachelor's degree in a life sciences related field or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
Valid driver's license.
Full Right to work in Germany.
Fluency in English and German language to at least C1 level (note that the interview will be held in German).
Benefits
Severely disabled applicants with the same aptitude will be given preferential treatment.
Reasonable accommodation to participate in the job application or interview process.
Administrative tasks such as expense reports and timesheets in a timely manner.
Job title
Senior Clinical Research Associate I/II – Senior Klinischer Monitor
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